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Mutagenic Impurities: Strategies for Identification and Control by Andrew Teasda

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Item specifics

Condition
Brand New: A new, unread, unused book in perfect condition with no missing or damaged pages. See all condition definitionsopens in a new window or tab
ISBN-13
9781119551218
Book Title
Mutagenic Impurities
ISBN
9781119551218
Publication Year
2021
Type
Textbook
Format
Hardcover
Language
English
Publication Name
Mutagenic Impurities: Strategies for Identification and Control
Author
Andrew Teasdale
Publisher
John Wiley & Sons AND Sons LTD
Subject
Biology
Item Weight
666g
Number of Pages
560 Pages

About this product

Product Information

Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control.

Product Identifiers

Publisher
John Wiley & Sons AND Sons LTD
ISBN-13
9781119551218
eBay Product ID (ePID)
27049955484

Product Key Features

Author
Andrew Teasdale
Publication Name
Mutagenic Impurities: Strategies for Identification and Control
Format
Hardcover
Language
English
Subject
Biology
Publication Year
2021
Type
Textbook
Number of Pages
560 Pages

Dimensions

Item Weight
666g

Additional Product Features

Title_Author
Andrew Teasdale
Country/Region of Manufacture
United States

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